NCT01322620

Brief Summary

This study is conducted in Africa, Asia, Europe, North America and South America. The purpose of the survey is to identify the key psychosocial issues affecting patients with haemophilia.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,236

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2011

Shorter than P25 for all trials

Geographic Reach
3 countries

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 23, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 24, 2011

Completed
2 months until next milestone

Study Start

First participant enrolled

June 3, 2011

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 29, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 29, 2012

Completed
Last Updated

February 23, 2017

Status Verified

February 1, 2017

Enrollment Period

9 months

First QC Date

March 23, 2011

Last Update Submit

February 20, 2017

Conditions

Congenital Bleeding DisorderHaemophilia AHaemophilia BHaemophilia A With InhibitorsHaemophilia B With InhibitorsRelatives to/Carers of Patients

Outcome Measures

Primary Outcomes (1)

  • To quantify the extent of key psychosocial factors affecting patients with haemophilia in their daily lives

    After 6 weeks (recruitment and data collection)

Secondary Outcomes (1)

  • To quantify how psychosocial factors are associated with treatment outcomes, compliance, health and general well-being

    After 6 weeks (recruitment and data collection)

Study Arms (1)

A

Other: No treatment given

Interventions

No treatment givenOTHER

No treatment given. Participants are to complete a questionnarie in the study.

A

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult males with haemophilia and parents/carers of children with haemophilia.

You may qualify if:

  • Males with haemophilia A or B (with or without inhibitors)
  • Parents/carers of children aged below 18 years with haemophilia A or B (with or without inhibitors)
  • Patients currently receiving treatment for haemophilia with one of the following: replacement factor VIII or replacement factor IX or a bypassing agent (recombinant factor VIIa or aPCC (Activated prothrombin complex concentrate))
  • Patients with haemophilia, not currently receiving treatment with replacement factor VIII or IX or a bypassing agent (as appropriate), but who have had at least one spontaneous bleed into one or more joints within the last 12 months
  • Subjects must have access to the internet, either at home or at a location convenient to them, be able to complete a paper questionnaire, or be available to attend a face-to-face interview (Algerian subjects only), to participate in the survey

You may not qualify if:

  • Inability to understand and comply with written and verbal instructions unless assisted at the haemophilia treatment centre (HTC) or by a relative

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Novo Nordisk Investigational Site

Mississauga, L4W 4XI, Canada

Location

Novo Nordisk Investigational Site

Madrid, 28033, Spain

Location

Novo Nordisk Investigational Site

Crawley, RH11 9RT, United Kingdom

Location

Related Publications (2)

  • Forsyth AL, Gregory M, Nugent D, Garrido C, Pilgaard T, Cooper DL, Iorio A. Haemophilia Experiences, Results and Opportunities (HERO) Study: survey methodology and population demographics. Haemophilia. 2014 Jan;20(1):44-51. doi: 10.1111/hae.12239. Epub 2013 Aug 1.

    PMID: 23902228RESULT

  • Witkop M, Guelcher C, Forsyth A, Hawk S, Curtis R, Kelley L, Frick N, Rice M, Rosu G, Cooper DL. Treatment outcomes, quality of life, and impact of hemophilia on young adults (aged 18-30 years) with hemophilia. Am J Hematol. 2015 Dec;90 Suppl 2:S3-10. doi: 10.1002/ajh.24220.

    PMID: 26619194RESULT

Related Links

MeSH Terms

Conditions

Hemophilia AHemophilia B

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders, InheritedBlood Coagulation DisordersHematologic DiseasesHemic and Lymphatic DiseasesCoagulation Protein DisordersHemorrhagic DisordersGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesGenetic Diseases, X-Linked

Study Officials

  • Global Clinical Registry (GCR, 1452)

    Novo Nordisk A/S

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 23, 2011

First Posted

March 24, 2011

Study Start

June 3, 2011

Primary Completion

February 29, 2012

Study Completion

February 29, 2012

Last Updated

February 23, 2017

Record last verified: 2017-02

Locations

ES(1)GB(1)CA(1)